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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , , Revision: 23, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , Revision: 12, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Alecensa (updated)

alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017, , Revision: 12, Authorised, Last updated: 11/08/2022
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Human medicine European public assessment report (EPAR): Grasustek (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019, , , Revision: 3, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020, , , , Revision: 27, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Upstaza (updated)

Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022, , , , Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Imvanex (updated)

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013, , , Revision: 21, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Zejula (updated)

Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017, , , Revision: 18, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Kaftrio (updated)

ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020, , , Revision: 8, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Signifor (updated)

pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012, , Revision: 14, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , Revision: 25, Authorised, Last updated: 08/08/2022
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , Revision: 11, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Braftovi (updated)

Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018, , Revision: 10, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Elaprase (updated)

idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007, , , Revision: 24, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Ervebo (updated)

recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019, , Revision: 7, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Nexviadyme (updated)

Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022, , Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)

SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022, , Revision: 1, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)

A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020, , Revision: 4, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Nexpovio (updated)

Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021, , Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Xofluza (updated)

Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021, , Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 6, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018, , Revision: 11, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)

SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021, , , Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Strimvelis (updated)

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016, , , Revision: 8, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Sogroya (updated)

Somapacitan, Growth
Date of authorisation: 31/03/2021, , , Revision: 1, Authorised, Last updated: 01/08/2022